OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET— 510(k) K991917

Name: FDA 510(k) clearance K991917
Creator: U.S. Food and Drug Administration
Published: 1999-07-12

Substantially Equivalent

Metrika, Inc.

FDA 510(k) clearance K991917 for OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET, Substantially Equivalent on 1999-07-12. Applicant: Metrika, Inc.. Device class: 1.

Clearance details

Applicant: Metrika, Inc.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1999-06-07
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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